TRUSELTIQ (infigratinib)

TRUSELTIQ (infigratinib) 

Self-Administration - oral

Indications for Prior Authorization:

• Cholangiocarcinoma – Indicated for treatment in adults with previously treated, unresectable locally advanced cholangiocarcinoma OR metastatic cholangiocarcinoma with fibroblast growth factor receptor two (FGFR2) fusion or other rearrangements, as detected by FDA-approved tests.
  • This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coverage Criteria:

For diagnosis of cholangiocarcinoma:

• Dose does not exceed 125 mg daily for 21 consecutive days followed by 7 days off therapy in 28-day cycles, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with one of the following:
  • Gastroenterologist
  • Hepatologist
  • Oncologist, AND
• Chart note documentation provided confirms diagnosis of cholangiocarcinoma, AND
• Disease is one of the following:
  • Unresectable, locally advanced OR
  • Metastatic, AND
• Disease has presence of fibroblast growth factor receptor 2 (FGFR2) fusion, or other rearrangements, as detected by an FDA-approved test OR a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Patient has been previously treated (e.g., gemcitabine, cisplatin, 5-flurorouracil, cisplatin, oxaliplatin, capecitabine, albumin bound paclitaxel)

Reauthorization Criteria:

For diagnosis of cholangiocarcinoma:

• Dose does not exceed 125 mg daily for 21 consecutive days followed by 7 days off therapy in 28-day cycles, AND
• Disease does not show signs of progression while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Dosing:
  • Dosage forms are 25 mg and 100 mg capsules
  • 125 mg orally once daily for 21 consecutive days, followed by 7 days off therapy, in 28-day cycles. Continue until disease progression or unacceptable drug toxicity occurs
  • Dose adjusted for adverse reactions:
    • 1st dose reduction: 100 mg
    • 2nd dose reduction: 75 mg
    • 3rd dose reduction: 50 mg
  • Mild and moderate renal impairment:
    • Recommended 100 mg orally once daily for 21 consecutive days, followed by 7 days off therapy, in 28-day cycles
  • Mild hepatic impairment:
    • Recommended 100 mg orally once daily for 21 consecutive days, followed by 7 days off therapy, in 28-day cycles
  • Moderate hepatic impairment:
    • Recommended 75 mg orally once daily for 21 consecutive days, followed by 7 days off therapy, in 28-day cycles
• Truseltiq should be taken 1 hour before or 2 hours after food at approximately the same time every day. Capsules should not be crushed, chewed or dissolved
• Avoid coadministration with strong or moderate CYP 3A inducers
• Avoid coadministration with strong or moderate CYP 3A inhibitors
• Avoid coadministration with gastric acid reducing agents. If coadministration cannot be avoided, stagger administration of Truseltiq from H2RA or long-acting antacid
• Ophthalmological examinations (including optical coherence tomography, OCT) should be conducted at baseline, 1 month, 3 months and then every 3 months thereafter for the duration of treatment
• Truseltiq can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification. Monitor for hyperphosphatemia during the duration of treatment

Policy Updates:

• 11/16/2021 – New policy reviewed by P&T.

References:

• Truseltiq [package insert]. San Francisco, CA: QED Therapeutics; 2021
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Hepatobiliary cancers, version 5.2021 – Sept 21, 2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary_blocks.pdf.  Accessed Oct 8, 2021.